Elobixibat plus sodium picosulfate with magnesium citrate for bowel preparation

JRCT ID: jRCTs041210067

Registered date:09/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Bowel preparation before colonoscopy
• Date of first enrollment: 09/09/2021
• Target sample size: 540
• Study type: Interventional
• Intervention(s): Randomized controlled trial for new method bowel preparation

Outcome(s)

• Primary Outcome: Bowel preparation scale (BBPS>=6, Per each segment>=2)

Secondary Outcome

(1) Patients' tolerability (Questionnaire)
(2) Incidence of adverse effects
(3) Polyp/adenoma detection rate,The number of polyp/adenoma
(4) Bowel preparation scale(BBPS>=8)
(5) Bowel preparation scale(Aronchick scale<=1)
(6) Time of bowel preparation
(7) The volume of the bowel cleansing solution

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 69age old
• Gender: Both

Include criteria

(1) Out-patients who are planned scheduled colonoscopy
(2) Patients aged 40 to 69 years old at the time of consent
(3) Patients who received sufficient explanation about the trial and agreed with signatures

Exclude criteria

(1) Patients who had been registered in this trial
(2) Patients who have allergic reaction of drugs used in this trial
(3) PS(ECOG)>=2
(4) Patients who have symptoms or signs of bowel obstruction or colorectal strictures
(5) Patients who had symptoms of constipations

Related Information

• Primary Sponsor: Hotta Kinichi
• Source(s) of Monetary Support: Nippon Chemiphar Co., Ltd.